Controlled positive end pressure expiratory device

ABSTRACT

A controlled positive end expiratory pressure device comprises a vertically disposed passageway having a frustoconical segment at its lower end in which is supported a ball. The bottom of the passageway is adapted to communicate with a source of expiratory air such that the expiratory air tends to raise the ball off its support at the bottom of the passageway in order to provide a path for flow of the expiratory air around the ball. In this manner, the device acts as a calibrated end pressure means for providing a positive end expiratory pressure for the test subject or patient, thereby providing for enhanced pulmonary function. The device is designed to be universal in that it can be used intraoperatively on common anesthesia machines or post operatively on common ventilator machines. In one form, it is a hand held, self-controlled, lung exerciser.

United States Patent Boehringer [451 Sept. 30, 1975 [76] Inventor: JohnR. Boehringer, 427 Parkview Dr., Wynnewood, Pa. 19096 [22] Filed: Sept.27, 1973 [21] Appl. No.: 401,130

[52] U.S. CL. 272/57 F [51] Int. Cl. A63B 23/00 [58] Field of Search128/145 R, 145 A, 2.08; 137/533.11, 533.13, 133.15; 272/57 F; 73/209;131/205, 214, 222, 224

[56] References Cited UNITED STATES PATENTS 1,672,394 6/1928 Sargentl37/533.13

1,965,333 7/1934 Connell 73/209 3,720,202 3/1973 Cleary 128/208 FOREIGNPATENTS OR APPLICATIONS 776,172 1935 France l37/533.13

Primary Examiner -Richard J. Apley Assistant Examiner-Joseph R. TaylorAttorney, Agent, or Firm-Paul & Paul [5 7 ABSTRACT A controlled positiveend expiratory pressure device comprises a vertically disposedpassageway having a frustoconical segment at its lower end in which issupported a ball. The bottom of the passageway is adapted to communicatewith a source of expiratory air such that the expiratory air tends toraise the ball off its support at the bottom of the passageway in orderto provide a path for flow of the expiratory air around the ball. Inthis manner, the device acts as a calibrated end pressure means forproviding a positive end expiratory pressure for the test subject orpatient, thereby providing for enhanced pulmonary function. The deviceis designed to be universal in that it can be used intraoperatively oncommon anesthesia machines or post operatively on common ventilatormachines. In one form, it is a hand held, self-controlled, lungexerciser.

16 Claims, 5 Drawing Figures US. Patent Sept. 30,1975

CONTROLLED POSITIVE END PRESSURE EXPIRATORY DEVICE This inventionpertains to a controlled positive pressure expiratory device, and moreparticularly to a convenient, sanitary means for providing a controlledpositive pressure of known calibration and relatively free flowcharacteristics for use in the protocol known as positive end expiratorypressure or PEEP either during surgery intraoperatively or on ventilatormachines used to support or to assist breathing.

A persons ability to inspire and expire a sufficient quantity of air isusually seriously impaired by many diseases of the respiratory system.Therapeutically, it is often desirable forceably to increase the lungeffectiveness and capacity of such patients by providing them with ameans or device providing an end expiratory pressure against which thelungs of the patient must be actuated to provide for enhanced pulmonaryfunction.

It is therefore the general object of the present invention to provide asimple, sanitary, aesthetically pleas ing, controlled positive endexpiratory pressure device which is economical to manufacture, easy touse, and reasonably precise in providing a predetermined level ofpositive end expiratory pressure for a patient.

It is a more specific object of this invention to provide a relativelysimple, disposable, easily useable, controlled positive end expiratorypressure device dependent totally on gravity and not easily susceptibleto mechanical malfunction or calibration error.

These objects, and others which will become apparent in the course ofthe subsequent discussion, are met, briefly, by a device consisting of avertically disposed passageway terminated at its lower end with afrustoconical segment in which is supported (or which is adapted tosupport) a spherical ball which is freely movable within the passagewayabove the point of its support. The passageway at its bottomcommunicates with a source of expiratory air from the test subject topatient. The dimensions of the passageway and frustoconical segment, aswell as the dimensions and mass of the ball are calibrated to provide apredetermined positive end expiratory pressure for pulmonary patients.

In one preferred form of this invention, the device communicates at itsbottom end with a horizontally disposed air passageway adapted to beheld in the mouth of a user such that the overall configuration of thedevice resembles a conventional smoke pipe and may be used as such bythe respiratory patient to exercise and thereby to enhance his lungfunction in a convenient and aesthetically pleasing manner.

The invention may be better understood by reference to the followingdetailed description taken in conjunction with the subjoined claims andthe attached drawings, in which:

FIG. 1 is a top view of the preferred form of the invention;

FIG. 2 is a sectional view, in the plane 22, of the device shown in FIG.1;

FIG. 3 is a partial sectional view of the device shown in FIG. 3, thesection taken along the plane 3-3 of FIG. 2; and

FIG. 4 is a sectional view of another form of the present invention.

FIG. 5 shows still another alternative embodiment.

Referring more specifically to FIG. 1, there is shown a top view of oneparticular preferred form of the positive end expiratory pressure deviceof the present in vention. More particularly, this device consists ofspherical ball 2 supported above the smaller lower circumference 4 of afrusto-conical lower segment of a vertically disposed passageway definedby sidewall 6 and covered by a top closure 8 having an opening 10therein of shape and size to retain spherical ball 2 within thepassageway defined by sidewall 6 and ensuring an air passageway aroundspherical ball 2 with spherical ball 2 forced against top closure 8. Inthe configuration of top closure 8 shown in FIG. 1, opening 10 is anelongated oval. It could as easily be any of a variety of other shapesor forms, including a plurality of circular holes or, in fact, any shapeother than a simple circle located on the axis of the verticallydisposed passageway. The reason such a simple axially disposed circlewould not be acceptable is that it would be susceptible to being closedby forcing spherical ball 2 against, and seated within, such a circularopening during a forceable expiration such as a cough. Furthermore, thisdesign is foolproof in that if installed upside down, it disablesitself. In the commercial embodiment of the device shown in FIG. 1,there is a large arrow on the side of the body showing proper flowdirection.

The details of top closure 8 and opening therein 10 may be better seenin the sectional view, FIG. 2, of the device shown in FIG. 1 taken alongthe plane 22, and in the sectional view of FIG. 3 taken along the plane33 of FIG. 2.

As best seen in FIG. 2, the device shown in FIG. 1 includes a verticallydisposed passageway 12 with a lower frusto-conical segment 14 in whichspherical ball 2 is supported, and through which passageway 12 isadapted to communicate through passageway 16 with a source of expiratoryair from a test subject or patient.

As shown in FIG. 2, in the preferred form of the present invention,lower frusto-conical segment 14 is inclined, with respect to thevertical, at an angle of about 3741; this angle depends morespecifically on the weight and diameter of the ball 2 and the diameterof the lower circumference 4. Vertical passageway 12 is also defined byan upper frusto-conical section vertically adjacent the lower conicalsection 14, the upper frusto-conical section terminating at its lowerend with a circumference coinciding with the upper circumference oflower frusto-conical section 14, the upper frusto-conical sectionextending to the top closure 8 of the device, and having an angularinclination, with respect to the vertical, on the order of 812, mostpreferably about 10 for the commerical embodiment previously referredto.

While this preferred form of the invention includes a doublefrusto-conical segment, vertically disposed passageway 12 may consist ofa continuous frusto-conical section of constant angular inclination,with respect to the vertical, on the order of 520. Preferably, however,a lower frusto-conical section of greater annular inclination acts as athroat for vertically disposed passageway 12, as well as a support forspherical ball 2 and provides for a number of improved functions, i.e.,prevents jamming, promotes sealing, provides a massive surface not ableto chip, etc.

By carefully manufacturing the device, the taper of passageway 12 urgesthe ball to float in an air stream at or below the pressure at which theball will seat thus giving a valve which will have simultaneously in onedesign low resistance to high flow (such as a cough) but accuratesensitivity to pressure to lift the ball from the seat. The lowresistance to high pressure is important to prevent rupture of lungtissue and pneumothorax which might be caused by a forced exhalation,such as a cough, through a flow dependent resistance.

In another form of the present invention, as shown in FIG. 4, verticalpassageway 12 communicates at its lower end with a horizontally extendedmember 18 adapted to be held in the mouth by a patient or user, theoverall configuration of horizontally disposed member 18 and the housingof vertically disposed passageway 12 resembling that of an ordinary handheld smoke pipe so that the user can be encouraged to exercise his lungfunction using the device in the manner of a conventional smoke pipe.

While the device of the present invention, as described and illustrated,generally includes a lower frusto-conical segment in a verticallydisposed passageway supporting a spherical ball, the spherical ball mayinstead restSsimply in a circular opening not including a frusto-conicalsegment. Because calibration of such de vices is more difficult andfunctioning of the device is not as effective as that with thefrusto-conical segment, this is a non-preferred form of the presentinvention. While, such a simple circular opening is used in a commercialembodiment of the smoke pipe lung exerciser of the present invention, itis probably not suitable for other applications because it is notinherently safe in that the ball may stick in the opening since theangle of the sidewall of the opening on which the ball is seated isgenerally below the angle of repose of the materials in question.Similarly, another, though much less preferred, form of the presentinvention is that in which the shape of the ball is changed. Forexample, a vertically guided rod (to which a variable amount of weightmay be attached) with a specifically designed lower seating surface maybe used. A simple spherical ball, however, provides a constant massregardless of orientation and has less of a tendency to stick than othernon-spherical shapes. The spherical ball shape is therefore preferred.

In the preferred forms of the present invention, expiratory air passesup through the bottom of a vertically disposed chamber, as shown in bothFIGS. 2 and 4, and, in order to escape upwardly therethrough, raisesspherical ball 2, of predetermined size and mass to provide a controlledamount of positive end pressure against which the expiratory air mustact in order to raise spherical ball 2 off its supporting surface withinvertically disposed passageway 12.

The expiratory air then raises spherical ball 2 off its support in thelower end of the vertically disposed passageway 12, the amount by whichthe ball is raised being determined by the weight and size of the ball,the dimensions of the passageway and the air (or gas) flow present. Thepassageway may be vertically calibrated so that the distance the ball israised can be used as an indication of the expiratory flow. Morenormally, the device is used as an end expiratory pressure regulator toencourage and to develop lung function and no such vertical calibrationis required.

In one particular form of the present invention, a device such as thatshown in FIG. 2, has a diameter at the lower circumference of the lowerfrusto-conical section 14 of 0.591 inch and a diameter at the uppercircumference of frusto-conical section segment 14 of 0.615 inch withthe angular inclination of the sidewalls of frustoconical section 14,with respect to vertical, being 39.

The angular inclination of the upper frusto-conical segment is 10, andthe spherical ball 2 supported therein, which is composed of stainlesssteel, has a diameter of 0.625 inch and a weight of 16.33 grams.

The basic variation in end pressure is obtained by varying ball material(glass, nylon, stainless steel), and varying orifice diameters to suit.The ball may also be hollowed out to change its effective weight or massmay be added above the ball to increase its effective weight, but theseare not preferred embodiments.

The devices of this invention may be configured such that the valves canbe stacked one on another (as in FIG. 4) to give addition of pressuressuch as 2.5 plus 5 give 7.5 cm H O total end pressure. In the commercialembodiments of this invention, the devices are clearly labeled withlarge color coded one-half inch high numbers on the side of the bodyplaced so that the adaptor system does not interfere with it.

The devices of this invention are generally designed so that they can bedisabled by turning them from the vertical. A side port version isproduced which makes the valve a suitable device for drawing samples ofexpired gas conveniently into a sample container.

In order further to enhance the utility of embodiments of the presentinvention other modifications may also be made. For example, increasedflexibility may result if the ball 2 is provided with an adaptableweight facility. That is, it may be recognized that variation of theforce with which the ball 2 bears down in the passageway l6proportionally varies the resistance of the ball 2 to input air flow.Thus, this force, or effective weight" of the ball may be changed eitherby directly altering the mass of the ball, or by exerting forces such asmagnetic force upon the ball 2. One manner in which the mass of the ball2 may be altered directly is to connect to the ball 2 a shaft whichprotrudes up wardly and out of the device. If such a shaft isconditioned for attachment of weights, any desired mass variation of theball 2 may result.

While this invention has been described with respect to particular formsthereof, it should not be interpreted as limited thereto. Instead, theappended claims are intended to cover all such equivalent modificationsof the present invention as would be obvious to those skilled in theart, and within the true spirit and scope of the present invention. Forexample, the sidewall 6 may be cylindrical in shape and terminated by ahemispherical surface, rather than the frusto-conical shape shown.Similarly, variation of the orifice, diameter of the ball, and specificgravity of the ball will have a predictable effect on the back pressureproduced during zero flow and during flow conditions. Likewise, thedevice may be modified as shown in FIG. 5 for a simpler exerciser. Inthat embodiment, a stem 501 defines a mouthpiece part 504 whichcommunicates with a cavity 505 in a body segment 502. Segment 502 isshown connected with a cap 503 defining a cavity 506 which exhausts viapart 507. The size of the cavities 505 and 506 and parts 504 and 507,together with the orientation of the stem 501 relative to the air flowpath, provide an inherent flow resistance function which, although lesssevere than foregoing embodiments, does provide a useful exerciserconfiguration.

I claim:

1. A controlled positive end pressure expiratory device comprising avertically disposed passageway terminated at the lower end by afrustoconical segment adapted to communicate at the bottom thereof witha source of expiratory air, and a spherical ball having a calibratedsize and effective weight, said passageway being adapted to receive saidspherical ball, said ball being freely movable vertically within saidpassageway above said segment and supportable by said segment betweenthe top and bottom thereof, said ball defining means for exerting asubstantial predetermined back pressure function to said source ofexpiratory air, in order to provide significant resistance to theexpiration of air by a user.

2. A device, as recited in claim 1, wherein the angular displacement,from vertical, of the sidewalls of said frusto-conical segment is 3. Adevice, as recited in claim 1, wherein said passageway includes a topcover having an opening therein, said cover and opening being adapted toretain said ball in said passageway and to assure an escape of air fromsaid passageway.

4. A device, as recited in claim 1, further including means fordirecting air entering said lower segment from the bottom thereof in astream aimed generally outwardly and tangentially with respect to saidfrustoconical segment and entering said segment offcenter with respectthereto.

5. A device, as recited in claim 1, wherein said'passageway communicatesthrough the bottom thereof with a horizontally disposed member adaptedto be held in the mouth of a test subject, the overall configuration ofsaid device being substantially similar to that of a hand held smokepipe.

6. A device as recited in claim 1 wherein said segment comprises a firstportion having sidewalls disposed at 520 from vertical, and a secondsection having substantially greater disposition to vertical to supportsaid ball in nonjamming fashion.

7. A device as described in claim 1 wherein said passageway defines aplurality of cavities, each including a spherical ball defining meansfor exerting a predetermined back pressure function to expiratory air insaid passageway.

8. A device as described in claim 7 wherein said housing means comprisesa plurality of separate interlocking portions, each such portiondefining one of said cavities and input and exhaust ports therefor,whereby a plurality of portions may be stacked upon one another toproduce aggregate devices having variable back pressure devices.

9. A device, as recited in claim 7 wherein each of said cavitiesincludes a frustoconical segment above and vertically adjacent the nextsuccessive cavity, said segments each having a first circumference atits upper end and a second circumference at itslower end, said secondcircumference being smaller than said first circumference andcommunicating with and being smaller than the top circumference of thenext lower cavity.

10. A device, as recited in claim 9, wherein the angular inclination,from vertical, of said second frustoconical segment is the same as thatof said first or lower segment.

11. A device, as recited in claim 9, wherein the angular inclination,from vertical, of said second frustoconical segment is less than that ofsaid first or lower segment.

12. A device, as recited in claim 9, wherein the angular inclination,from vertical, of said first segment is 374l and that of said secondsegment is 812.

13. A controlled positive end pressure expiratory device comprising avertically disposed passageway with a circular opening at its lower endadapted to communicate with a source of expiratory air, and a sphericalball having a calibrated size and effective weight, said passagewaybeing adapted to receive said spherical ball having a diameter greaterthan that of said opening and being freely movable vertically withinsaid passageway and above said opening, said ball defining means forexerting a substantial predetermined back pressure function to saidsource of expiratory air, in order to provide significant resistance tothe expiration of air by a user.

14. A device as described in claim 13 wherein said means for exertingoperates responsively to the specific gravity of said ball, the diameterof said ball, and the size of said opening.

15. A device as described in claim 14, and further including means forvarying force exerted by said ball against flow of expiratory air fromsaid opening.

16. A device as described in claim 14, wherein said device is providedwith means for sampling the expiratory air flowing in said passageway.

1. A controlled positive end pressure expiratory device comprising avertically disposed passageway terminated at the lower end by afrustoconical segment adapted to communicate at the bottom thereof witha source of expiratory air, and a spherical ball having a calibratedsize and effective weight, said passageway being adapted to receive saidspherical ball, said ball being freely movable vertically within saidpassageway above said segment and supportable by said segment betweenthe top and bottom thereof, said ball defining means for exerting asubstantial predetermined back pressure function to said source ofexpiratory air, in order to provide sIgnificant resistance to theexpiration of air by a user.
 2. A device, as recited in claim 1, whereinthe angular displacement, from vertical, of the sidewalls of saidfrusto-conical segment is 10*.
 3. A device, as recited in claim 1,wherein said passageway includes a top cover having an opening therein,said cover and opening being adapted to retain said ball in saidpassageway and to assure an escape of air from said passageway.
 4. Adevice, as recited in claim 1, further including means for directing airentering said lower segment from the bottom thereof in a stream aimedgenerally outwardly and tangentially with respect to said frusto-conicalsegment and entering said segment off-center with respect thereto.
 5. Adevice, as recited in claim 1, wherein said passageway communicatesthrough the bottom thereof with a horizontally disposed member adaptedto be held in the mouth of a test subject, the overall configuration ofsaid device being substantially similar to that of a hand held smokepipe.
 6. A device as recited in claim 1 wherein said segment comprises afirst portion having sidewalls disposed at 5*-20* from vertical, and asecond section having substantially greater disposition to vertical tosupport said ball in nonjamming fashion.
 7. A device as described inclaim 1 wherein said passageway defines a plurality of cavities, eachincluding a spherical ball defining means for exerting a predeterminedback pressure function to expiratory air in said passageway.
 8. A deviceas described in claim 7 wherein said housing means comprises a pluralityof separate interlocking portions, each such portion defining one ofsaid cavities and input and exhaust ports therefor, whereby a pluralityof portions may be stacked upon one another to produce aggregate deviceshaving variable back pressure devices.
 9. A device, as recited in claim7 wherein each of said cavities includes a frustoconical segment aboveand vertically adjacent the next successive cavity, said segments eachhaving a first circumference at its upper end and a second circumferenceat its lower end, said second circumference being smaller than saidfirst circumference and communicating with and being smaller than thetop circumference of the next lower cavity.
 10. A device, as recited inclaim 9, wherein the angular inclination, from vertical, of said secondfrusto-conical segment is the same as that of said first or lowersegment.
 11. A device, as recited in claim 9, wherein the angularinclination, from vertical, of said second frusto-conical segment isless than that of said first or lower segment.
 12. A device, as recitedin claim 9, wherein the angular inclination, from vertical, of saidfirst segment is 37*-41* and that of said second segment is 8*-12*. 13.A controlled positive end pressure expiratory device comprising avertically disposed passageway with a circular opening at its lower endadapted to communicate with a source of expiratory air, and a sphericalball having a calibrated size and effective weight, said passagewaybeing adapted to receive said spherical ball having a diameter greaterthan that of said opening and being freely movable vertically withinsaid passageway and above said opening, said ball defining means forexerting a substantial predetermined back pressure function to saidsource of expiratory air, in order to provide significant resistance tothe expiration of air by a user.
 14. A device as described in claim 13wherein said means for exerting operates responsively to the specificgravity of said ball, the diameter of said ball, and the size of saidopening.
 15. A device as described in claim 14, and further includingmeans for varying force exerted by said ball against flow of expiratoryair from said opening.
 16. A device as described in claim 14, whereinsaid device is provided with means for sampling the expiratory airflowing in said passageway.